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Summary

for people ages 18 years and up (full criteria)
study started
estimated completion:

Description

Summary

This is a single-center cross-sectional imaging study in patients with localized lung cancer undergoing immunotherapy with or without stereotactic radiation therapy as part of the companion clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer). Each patient will undergo a single [18F]F-AraG PET exam as part of this study. [18F]F-AraG will be administered at a single time point intravenously prior to PET imaging. Whole-body PET will be acquired along with a whole body low dose CT (PET/CT) used for attenuation correction and anatomic localization of [18F]F-AraG uptake, SUV calculation, and volumetric selection for radiomic analyses.

Official Title

T-Cell PET Imaging With [18F]F-AraG and Radiomics to Guide Combined Radiation and Systemic Immune Modulating Therapies

Details

This is a single-center cross-sectional imaging study in patients with localized lung cancer undergoing immunotherapy with or without stereotactic radiation therapy as part of the companion clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer). Each patient will undergo a single [18F]F-AraG PET exam as part of this study. [18F]F-AraG will be administered at a single time point intravenously prior to PET imaging. Whole-body PET will be acquired along with a whole body low dose CT (PET/CT) used for attenuation correction and anatomic localization of [18F]F-AraG uptake, SUV calculation, and volumetric selection for radiomic analyses.

A total of 20 patients will be enrolled over an accrual period of approximately 12 months. Approximately 10 patients will be enrolled in the immunotherapy alone cohort and approximately 10 patients will be enrolled in the immunotherapy and stereotactic radiation therapy cohort.

Patients will be evaluated one day and one week via telephone after each radiopharmaceutical injection for safety follow-up. All adverse events will be recorded. Due to the noninvasive and non-therapeutic nature of the study, potential risks of the study are anticipated to be low.

Keywords

Non-small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung Pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age greater than or equal to 18 years
  2. Histologically or cytologically documented stage I-IIIA non-small cell lung cancer(NSCLC)
  3. Eligible for with plan to undergo immunotherapy alone or both immunotherapy and stereotactic radiation therapy as part of NCT03217071
  4. In female patients, negative pregnancy test with no plans to become pregnant during the duration of the study
  5. Able to provide informed consent and follow the study guidelines

You CAN'T join if...

  1. Female patients who are pregnant or breastfeeding

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03311672
Phase
Phase 2
Lead Scientist
Benjamin Franc
Study Type
Interventional
Last Updated
October 11, 2017
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